Cleared Traditional

K923272 - COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR

K923272 is an FDA 510(k) clearance for COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGE..., manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K923272 · Cobe Laboratories, Inc. · Cardiovascular device
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May 1993
Decision
309d
Days
Class 2
Risk

K923272 is an FDA 510(k) clearance for the COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Arvada, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K923272

510(k) Number K923272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date May 11, 1993
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 125d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K923272.
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · Medtronic Vascular · Jun 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
K925075 · 3M Health Care, Sarns · Jun 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · 3M Health Care, Sarns · Jun 1993
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · Medtronic Vascular · Feb 1993
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
K922933 · Sorin Biomedica, Fiat, USA, Inc. · Nov 1992
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992